Accessing Clinical Research

Clinical research is fundamental to the translation of new medical discoveries into new treatment options for the clinic. Raising awareness of clinical research through education and discussion tools such as this will help ensure a healthy clinical research industry, bringing ongoing and early access of new treatments to patients, and career alternatives for those with an interest in contributing to better health in the future

Wednesday, November 21, 2007

Well, it has been a busy few weeks but my new website is created, so this will be my last post to this blog, but not the last time I blog. My new website has a blog where I will continue sharing my thoughts and adventures. Please visit

Thursday, November 8, 2007

There was an article written on Medscape recently that called for the same standards of evidence to apply to dietary supplements as conventional medicines. As you might expect, many would consider this a contentious issue, and one that has been previously discussed on this blog. I thought you might be interested in the responses to this article on Medscape.http://www.medscape.com/viewarticle/564261?src=mpYou'll need to log-in to the website, but at least that is free!

Thursday, November 1, 2007

Coinciding with Research Australia's whirlwind country-wide promotion trip for 'Thank You Day' which acknowledges the efforts of medical researchers, the NHMRC yesterday launched a new book - Great minds in Australian research, which highlights the work of 10 of Australia’s most eminent medical researchers. Here's the press release if you're interested in learning more....http://www.nhmrc.gov.au:80/news/media/rel07/071031.htm

Consumers International this week released a report on pharmaceutical marketing practices in developing countries, with a call to better regulation of these practices. http://www.consumersinternational.org/. From reading the Consumers International report, that call is probably justified. It looks like there are some dodgy practices going on by some companies, which disappoints me, since I like to believe pharma companies try to act responsible and ethically. This report release was followed up by a press release from Medicines Australia supporting better practices in developing countries, and distinguishing Australia from the same dodgy practices. http://www.medicinesaustralia.com.au/pages/images/MR%20Oct%203107%20MA%20supports%20robust%20global%20standard.pdf

I had a couple of internal debates pondering this information (and I'm not defending unethical or irresponsible behaviour when I throw these ideas out there), and they were:

1. What is the cultural environment for business in those countries and are pharma companies just doing 'what everyone else does' in those countries to get by? This may seem strange to say, but are we just trying to stamp our ideals on other countries who don't operate in the same way, any differently than, dare I say, trying to stamp our ideas of democracy and equality on other cultures that operate differently?

I've had the opportunity personally to do a business transaction in what might have been termed a 'developing' country in Eastern Europe over the past couple of years, completely unrelated to the industry we are talking about here. I came into the deal with my 'western' ideas of law, ethics, etc only to find they did not fit in this other country. The locals however had no issue with the way things were done. So in this situation, who was right? Should I have imposed my way of thinking on them? If I had, then I probably wouldn't have continued with the business deal, and that would have had its own economic effect on the people I was dealing with. Instead, I chose to trust the locals were operating appropriately for their environment, and continued with the business deal. Perhaps I was at fault, I don't know, but it is not an easy question. Now perhaps over time, this other country might decide to change their way of thinking and doing things, and I think providing lots of perspectives can help them on their journey. But I think it is really for local countries to consider, change, legislate, etc as appropriate for their population, rather than forcing that change from outside because of some perspective we have that differs from them.

2. I think we need to debate what are considered 'bribes' and 'gifts'.

Now the gifts like travel and expensive dinners etc perhaps need to be questionned, as I think they are more likely to be persuasive in prescribing behaviours, whether doctors think they are immune to it or not. But some of the 'gifts' received by the Malaysian doctor in the report included pens, pads, advertising brochures, things you could just as easily source from any number of places, and I would personally consider pretty innocuous.

I know I collect pens or notepads whenever they are freely available, but it probably doesn't influence my decision to buy from, work with, etc that company. I'm just saving myself the money of buying stationary. Is producing advertising brochures and sending them to doctors, any different to the 5-10 electrical /department store brochures and 5-10 restaurant brochures I seem to get from the same companies over and over in my letterbox every week? (Stop the paper waste!... but that's a different issue). Like it or not, these brochures educate me about what is available, particularly when I am short of time and don't necessarily go looking for this information myself, but it doesn't mean I am going to buy what's in them. Yes, the company may be closer to the top of my mind if I am interested in a product, or it may have stimulated an interest in buying that product. But if I am interested in something, it usually just prompts me to seek more information on that product and other suppliers of similar products - either to find a more competitively priced product, or a product with better specification. Maybe I am not the average person in my buying habits, but I find it hard to believe doctors wouldn't use a similar 'prescribing' philosophy, if they really had the best interests of their patients at heart.

In Australia, we have an industry code of conduct, which can be found on the Medicines Australia website, along with a great set of FAQs on the subject advertising and promotional activities. http://www.medicinesaustralia.com.au/pages/page17.asp#anchor18. This is a self-regulated code, so is still subject to easier violation that if legislated.

It should be known that clinical research, and not just marketing promotion, is subject to the same guidelines, because it could be argued by some that clinical research is just early promotional activity. As a company clinical researcher, it became increasingly difficult sometimes to have a friendly working relationship with the clinicians and staff you partner with to complete the studies. Company sponsored clinical research is a very matrixed environment with stakeholders under the umbrella of multiple employers. It is OK for a nurse to share in morning tea or have lunch with you, so long as they pay, but as a pharma company employee, you are made to feel it is not necessarily OK for you to reciprocate, for fear of recriminations over bribery of doctors. And what about the 'stickie notes' that are often provided, which until the advent of electronic data collection forms were the one tool of trade the clinical research associate couldn't live without?

This debate on gifts and what is reasonable is a necessary one. However, with so much publicity about poor practice, it must be difficult for consumers to distinguish between when they are at risk, or when people in other countries are actually the ones at risk. Debate is good, so long as it is contextualised and balanced, and I'm not sure that is the case in the media, leading to a very mistrustful relationship with the drug industry.

For my first job post university in a medical research institute, I had a PI that was part slave driver, control freak, science wonk and rising start (or at least he thought so). Add 'Swiss' and their known penchant for precision to the mix, and you can probably understand my dilemma. Although I have to admit, attention to detail, if it wasn't before is now very much a part of my repetoire, probably making me at times a tough boss to please, and delegation a challenge! Worst 2 years of my career professionally, though the Friday night bonding pub sessions at the 'Marly' with fellow suffering teammates made for good times, and some of those friendships still survive 12 years post-PI #1. PI#1 had me searching for ways out of the lab (or at least His lab).

How bad must it have been when the option I chose next was to do a PhD. Nothing like working at least as hard, for less money, but at least the atmosphere was better. PI#2 was a mix of 'big talker' and 'laid-back'. I only ever saw him at times when I needed to apply for money or ethics review, had to present at the company who sponsored my research, or to get my PhD chapters reviewed, but because of the 'big talk', he knew how to spin to get things done, so probably a good mix on balance.

After psycho-boss PI#1, to go to the complete opposite was a bit scary and stressful (after all, how would I cope without PI#1 breathing down my neck, telling me what to do and think and criticising everything? Was I capable of thinking on my own? ). PI#1 refused to believe I was capable of doing a PhD, as he went to great lengths to tell me. I had asked to do a PhD under PI#1, but he turned me down. I guess I can be grateful to him for that at least, and sparing me another 3 years of pain under his supervision. (You can tell can't you - no scars here from the PI#1 experience, and we wonder why people don't do or leave science!) Thankfully, doing the PhD showed me I was capable of original thought and led me to believe I could have some value as a scientist. PI#2 offered me a job post PhD which set me on the path to industry and out of the lab, for which I am truly grateful, so he wasn't so bad.

I think we could translate some of these cartoons to the arena of clinical research PIs, of whom I think I've encountered every type over the past 8 years, but a few minor revisions would be necessary. For example the Big Talker Clinical PI - same text out of his mouth would be appropriate. The +ve = good for encouraging others to become involved with the trial, or later publicity of the new treatment. The -ve = overdelegates and never available to sign off a CRF or paperwork. If I had some cartooning skills, I might just have a go at the revisions, but alas, I'll spare the world from my attempts at drawing!

Tuesday, October 30, 2007

Australia's not the only country trying to tackle the enormous inefficiencies created by trying to agree clinical trial contract between sponsors and individual institutions. But the UK is just one short step ahead of us, having released this week their standard CRO contract. http://www.medicalnewstoday.com/articles/86856.php

With any luck, Australia will manage to tie up our single CRO contract in the next few months. We then just need institutions to accept the standard contracts on a sponsor specific basis, and we should have put an end to the months delays seen at some hospitals and institutions trying to agree these contracts.

I will be interested to hear Nov21 at the ARCS meeting an update on the progress of acceptability of the standard sponsor contract that has been implemented in Australia's Eastern-board states and whether it is achieving the time gains everyone hoped it would.

Monday, October 22, 2007

How quickly time has passed since the last entry. I avoided the election debate between our two fearless political leaders last night in favour of catching up with a former colleague visiting from the UK for an investigator meeting. Mind you, I ended the evening sitting on my balcony debating the pros and cons of each political party with my husband anyway, so not a completely politics free night. I suspect with 5 weeks to go to the election, it won't be our last debate on the subject.

Thought I'd share a few of the interesting clinical research stories I've come across in the past few days.

I think this is great to see, and certainly will help set the scene for Africa to be the next powerhouse in clinical trials, after the Asian revolution. Of course, there still exist alot more issues and barriers to research in Africa, to avoid occurences such as that for which Pfizer is currently defending (http://www.outsourcing-pharma.com/news/ng.asp?n=80208-pfizer-nigeria-trovan-clinical-trial), but hopefully time and education will see these ironed out.

2. http://www.channelnewsasia.com/stories/singaporelocalnews/view/306653/1/.htmlSingapore wants to become the world's leading centre for neuroscience and their government are putting in place infrastructure to help facilitate that. Part of that infrastructure, includes the development of a national Academic Clinical Research Organisation (ACRO) to be set up by early next year to encourage more clinical trials to be conducted in Singapore.

I suppose this idea is something like the NHMRC Clinical Trials Centre in Australia.

What I thought most interesting about that is the reference to the way the Indian government is supporting clinical research in India, which appears to be proving very successful for developing the country's CRO industry - the exemption of CROs from service tax obligations.

4. In light of all these news stories about research in developing countries, it was a timely reminder when I came across this blog today, which among other things has a library with a few articles on the ethics of research in developing countries: http://katescasebook.wordpress.com/reading/

Anyone who has working in multiple countries will know this is a world-wide phenomena, and one that is likely to continue for some time, given the rapidly expanding clinical research environment, both in the traditional regions for research such as Europe, US, and might you say, Australia, but also for the newly establishing developing countries like India, China, Africa, to name a few.

What is the answer? One answer explored in this article is key I think - publicise the industry as a career choice. Most people I know fell into clinical research by accident, rather than design. Had I known about the clinical research career pathway earlier, then I probably wouldn't have spent years in a lab first. Mind you, if we convert everyone into being clinical researchers, then we won't people left pursuing basic and pre-clinical research, the foundations necessary before clinical research can be pursued, so there must be some balance.

We need to cast off the image of science as only people wearing labcoats and glasses, and make it as attractive and popular as being a sports hero, or movie star (well, we can dream anyway). Then we might have more people pursuing science, for the rewards it can bring both personally, and to the population as a whole. I think the popular science TV shows have gone some way to helping this, but we've still got some way to go yet.

Monday, October 15, 2007

A long lost friend was in touch over the weekend to chat with me about my comments on research in CAM - complementary and alternative medicine. I met this friend, who I'll refer to as SA, while we were both progressing through the challenges of doing a PhD, although she was close to finishing as I was embarking on my journey. I always really enjoyed our conversations, as she was far more broadly read than myself, and always had interesting perspectives to share... an old soul perhaps. As she was finishing her traditional scientific pursuits, SA became interestes in Reiki and CAM. At the time, I listened, but couldn't really understand, and remained a sceptic. SA moved away pursuing her CAM career, and my traditional science career continued.

Four to five years later, I was needing some stress relief in my life, and Reiki again crossed my path. This time, I was more open to the idea as I guess the idea had had time to ferment since SA first introduced me to it. I did the starter course, finding Reiki a useful technique to relax myself somewhat. While still somewhat sceptical, it seemed to work so what harm in using it on myself, even if not necessarily competent (or more likely patient enough) to do it on others.

Some time has passed since then, and it was a welcome surprise to hear again from my old friend and have her share some of her challenges in combining good science with CAM, given the hurdles of acceptability of CAM in the country she now resides in.

So to set the record somewhat straight, there are some places trying to conduct research in CAM, which I was unaware of, due to my surroundings in a conventional medicine environment perhaps, although there remains some challenges in the area. For those interested, here are a few links to interesting CAM websites, both in Aus and overseas, to help balance the debate:

About Me

From the lab to clinical research, my career has meandered ever closer to the consumers that benefit from scientific endeavours. My latest passion is bringing clinical research out into the open, demystifying the process for consumers and research professionals alike. With greater understanding, comes less fear and increased participation, which will help solidify our ongoing early access to new potential medical treatments in the future.